Acute Implantation of a Bioresorbable Polymer Scaffold in Patients With Complete Thoracic Spinal Cord Injury: 24-Month Follow-up From the INSPIRE Study

Kee D Kim, K Stuart Lee, Domagoj Coric, James S Harrop, Nicholas Theodore, Richard M Toselli, Kee D Kim, K Stuart Lee, Domagoj Coric, James S Harrop, Nicholas Theodore, Richard M Toselli

Abstract

Background: Based on 6-month data from the InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurological Recovery in Patients with Complete Thoracic Spinal Cord Injury (INSPIRE) study (NCT02138110), acute implantation of an investigational bioresorbable polymer device (Neuro-Spinal Scaffold [NSS]) appeared to be safe in patients with complete thoracic spinal cord injury (SCI) and was associated with an ASIA Impairment Scale (AIS) conversion rate that exceeded historical controls.

Objective: To evaluate outcomes through 24 months postimplantation.

Methods: INSPIRE was a prospective, open-label, multicenter, single-arm study. Eligible patients had traumatic nonpenetrating SCI with a visible contusion on MRI, AIS A classification, neurological level of injury at T2-T12, and requirement for open spine surgery ≤96 hours postinjury.

Results: Nineteen patients underwent NSS implantation. Three patients had early death determined by investigators to be unrelated to the NSS or its implantation procedure. Seven of 16 evaluable patients (44%) had improvement of ≥1 AIS grade at 6 months (primary end point) to AIS B (n = 5) or AIS C (n = 2). Three patients with AIS B at 6 months had further neurological improvement to AIS C by 12 (n = 2) and 24 (n = 1) months, respectively; none have deteriorated per latest available follow-up. No unanticipated or serious adverse device effects were reported.

Conclusion: In this small group of patients with complete thoracic SCI, acute NSS implantation within the spinal cord appeared to be safe with no long-term neurological issues identified during the 24-month follow-up. Patients remain stable, with additional AIS conversions observed in some patients at 12 months and beyond. These data further support the safety and probable benefit of NSS implantation in this patient population.

Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc on behalf of Congress of Neurological Surgeons.

Figures

FIGURE.
FIGURE.
Changes in AIS grade from preimplantation in patients with complete (AIS A) thoracic spinal cord injury who responded to NSS implantation. aResponders are defined as patients who met the primary end point (improvement of ≥1 AIS grade at the 6-month postimplantation follow-up visit), bPediatric is defined as age ≤21 years per the US Food and Drug Administration definition for medical devices. c2-month postimplantation visit for this patient was not required per protocol approved at the time. AIS, American Spinal Injury Association (ASIA) Impairment Scale; HD, hospital discharge; M, month; NLI, neurological level of injury; NSS, Neuro-Spinal Scaffold.

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Source: PubMed

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